Ventana Medical Systems (Ventana), a member of the Roche Group, has announced the global launch of its BRAF V600E immunohistochemistry (IHC) test, which is designed to detect the BRAF V600E mutation in a variety of tumours.
It is reportedly the only fully automated IHC test available in the market to provide highly sensitive and specific, standardised testing method for the assessment of the BRAF V600E mutation in tissue.
The new assay, which will function on all Ventana Benchmark IHC platforms with the OptiView DAB IHC Detection Kit, can provide easy interpretation and seamless integration into a laboratory’s workflow.
The BRAF V600E mutation is found to play a prominent role in a variety of tumours, including colorectal cancer and other cancers such as melanoma, papillary thyroid cancer and hairy cell leukemia.
Ventana president Mara G Aspinall said as a leader in cancer diagnostics, Ventana is committed to providing unique immunohistochemistry assays for aiding in the diagnosis and management of a variety of cancers.
"The BRAF V600E (VE1) IHC in vitro diagnostic is a valuable addition to our assay portfolio to aid physicians and patients in the important stratification of colon cancer," Aspinall said.
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Ventana is launching the BRAF V600E IHC test as a US Class I exempt/CE- in vitro diagnostic product.
The Ventana BRAF V600E (VE1) Mouse Monoclonal Primary Antibody IHC assay is the result of the Ventana’s exclusive license agreement that was signed with German Cancer Research Centre (Deutsches Krebsforschungszentrum, DKFZ) and the University Hospital Heidelberg, Germany to market the novel IHC primary antibody that detects the V600E mutated BRAF protein.
In addition, Roche offers the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic for Zelboraf (vemurafenib).
In a pivotal BRIM-3 study, the cobas V600 Mutation Test demonstrated that only patients selected by it benefited from Zelboraf therapy.
The launch of Ventana IHC BRAF assay expands Roche’s BRAF V600E testing beyond melanoma.
Image: Colorectal carcinoma positive with BRAF V600E (VE1) IHC with OptiView DAB IHC detection. Photo: courtesy of Ventana Medical Systems, Inc.